FDA Approves Bylvay (odevixibat) for the Treatment of Pruritus in Patients with Progressive Familial Intrahepatic Cholestasis (PFIC)
BOSTON, July 20, 2021 (GLOBE NEWSWIRE) -- Albireo Pharma, Inc. (Nasdaq: ALBO), a rare liver disease company developing novel bile acid modulators, today announced U.S. Food& Drug Administration (FDA) approval of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 20, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Octapharma ’s Octagam 10% for Adult Dermatomyositis
PARAMUS, N.J.--(BUSINESS WIRE) July 20, 2021 --The U.S. Food and Drug Administration (FDA) has granted approval to Octapharma USA for Octagam® 10% [Immune Globulin Intravenous (Human)], the first and only intravenous immunoglobulin (IVIg) to be... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 20, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Fexinidazole as the First All-Oral Treatment for Sleeping Sickness
July 19, 2021 -- The US Food and Drug Administration (FDA) has approved fexinidazole as the first all-oral treatment for both stages of the Trypanosoma brucei gambiense form of sleeping sickness (Human African trypanosomiasis) in patients 6 years of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 19, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) for the Prevention of Invasive Pneumococcal Disease in Adults
KENILWORTH, N.J.--(BUSINESS WIRE)-- (NYSE: MRK), known as MSD outside the United States and Canada, today announced the U.S. Food and Drug Administration (FDA) approved Vaxneuvance (Pneumococcal 15-valent Conjugate Vaccine) (pronounced... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 16, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Rezurock (belumosudil) for the Treatment of Patients with Chronic Graft-Versus-Host Disease (cGVHD)
NEW YORK, NY / ACCESSWIRE / July 16, 2021 / Kadmon Holdings, Inc. (Nasdaq:KDMN) today announced that the U.S. Food and Drug Administration (FDA) has approved Rezurock™ (belumosudil) 200 mg once daily (QD) for the treatment of adult and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 16, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Kerendia (finerenone) for the Treatment of Patients with Chronic Kidney Disease Associated with Type 2 Diabetes
WHIPPANY, N.J.-- July 9, 2021 (BUSINESS WIRE)-- Bayer announced today the United States (U.S.) Food and Drug Administration (FDA) has approved Kerendia (finerenone), a first-in-class nonsteroidal mineralocorticoid receptor antagonist (MRA) indicated... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 9, 2021 Category: Drugs & Pharmacology Source Type: news

U.S. FDA Grants Regular Approval and Expands Indication for Padcev (enfortumab vedotin-ejfv) for Patients with Locally Advanced or Metastatic Urothelial Cancer
Regular Approval Based on Overall Survival Results from Confirmatory EV-301 Trial First and Only FDA-Approved Therapy for Urothelial Cancer Patients Who Are Cisplatin-Ineligible and Have Previously Received One or More Prior Therapies, Based on... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 9, 2021 Category: Drugs & Pharmacology Source Type: news

Lupin Announces FDA Approval of Supplemental New Drug Application for Solosec (secnidazole) for the Treatment of Trichomoniasis
BALTIMORE, July 1, 2021 /PRNewswire/ --Lupin Pharmaceuticals, Inc., the U.S. based wholly-owned subsidiary of global pharma major Lupin Limited (Lupin), announced today that the U.S. Food and Drug Administration (FDA) has approved the company's... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - July 1, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Rylaze for the Treatment of Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
DUBLIN, June 30, 2021 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the U.S. Food and Drug Administration (FDA) approval of Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) for use as a component of a... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 30, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) for the Treatment of Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma
DUBLIN, June 30, 2021 /PRNewswire/ -- Jazz Pharmaceuticals plc (Nasdaq: JAZZ) today announced the U.S. Food and Drug Administration (FDA) approval of Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) for use as a component of a... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 30, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Verkazia (cyclosporine ophthalmic emulsion) for the Treatment of Vernal Keratoconjunctivitis
EMERYVILLE, Calif.--(BUSINESS WIRE) June 24, 2021 --Santen Inc., the U.S. subsidiary of Santen Pharmaceutical Co., Ltd. (hereinafter, Santen), a global company focused exclusively on eye care, today announced that the U.S. Food and Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 24, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Pradaxa (dabigatran) as First Oral Blood Thinning Medication for Children
June 21, 2021 -- Today, the U.S. Food and Drug Administration approved Pradaxa (dabigatran etexilate) oral pellets to treat children 3 months to less than 12 years old with venous thromboembolism (a condition where blood clots form in the veins)... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 21, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Soaanz (torsemide) for Edema Treatment in Patients with Heart Failure and Renal Disease
VIENNA, VA. (PRWEB) JUNE 21, 2021 Sarfez Pharmaceuticals announced today approval by the U.S. Food and Drug Administration (FDA) of the Virginia-based company’s New Drug Application for Soaanz, a once-a-day improved formulation of the loop... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 21, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Astepro Allergy (azelastine) Nasal Spray for Over-the-Counter Use
WHIPPANY, N.J.--(BUSINESS WIRE) June 17, 2021-- Bayer announced today that the U.S. Food and Drug Administration (FDA) has approved Astepro Allergy (Azelastine HCI .15%) as an over-the-counter (OTC) product for the temporary relief of nasal... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 17, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Blueprint Medicines' Ayvakit (avapritinib) for the Treatment of Adults with Advanced Systemic Mastocytosis
First precision therapy that specifically targets the primary driver of the disease Durable clinical responses, including complete remissions, shown in patients with or without prior treatment Full approval supported by robust efficacy and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 16, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Rezipres (ephedrine hydrochloride injection) for Hypotension During Anesthesia
DEER PARK, Ill., June 15, 2021 (GLOBE NEWSWIRE) -- Eton Pharmaceuticals, Inc (Nasdaq: ETON) today announced that the U.S. Food and Drug Administration (FDA) has approved Rezipres (ephedrine hydrochloride injection) for the treatment of clinically... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 15, 2021 Category: Drugs & Pharmacology Source Type: news

U.S. Food and Drug Administration Approves New Formulation of Epclusa, Expanding Pediatric Indication to Treat Children Ages 3 and Older With Chronic Hepatitis C
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jun. 10, 2021-- Gilead Sciences, Inc. (Nasdaq: GILD) announced today that the U.S. Food and Drug Administration (FDA) has approved an expansion of the pediatric indication of Epclusa (sofosbuvir/velpatasvir) for... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 10, 2021 Category: Drugs & Pharmacology Source Type: news

Vertex Announces U.S. FDA Approval for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in Children With Cystic Fibrosis Ages 6 through 11 With Certain Mutations
BOSTON--(BUSINESS WIRE)--Jun. 9, 2021-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced the U.S. Food and Drug Administration (FDA) approved expanded use of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to include... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 9, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Prevnar 20 (pneumococcal 20-valent conjugate vaccine) for Adults Ages 18 Years or Older
First approval of a conjugate vaccine that helps protect against 20 serotypes responsible for the majority of invasive pneumococcal disease and pneumonia,1,2,3,4,5,6,7 including seven responsible for 40% of pneumococcal disease cases and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 8, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Grants Accelerated Approval for Aduhelm (aducanumab-avwa) for the Treatment of Alzheimer ’s Disease
CAMBRIDGE, Mass. and TOKYO, June 07, 2021 (GLOBE NEWSWIRE) -- Biogen (Nasdaq: BIIB) and Eisai, Co., Ltd. (Tokyo, Japan) today announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval for Aduhelm™... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 7, 2021 Category: Drugs & Pharmacology Source Type: news

Alexion Announces FDA Approval of Ultomiris (ravulizumab-cwvz) for Children and Adolescents with Paroxysmal Nocturnal Hemoglobinuria (PNH)
BOSTON--(BUSINESS WIRE)--Jun. 7, 2021-- Alexion Pharmaceuticals, Inc. (NASDAQ:ALXN) today announced the U.S. Food and Drug Administration (FDA) has approved the expanded use of Ultomiris (ravulizumab-cwvz) to include... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 7, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Tembexa (brincidofovir) for the Treatment of Smallpox
DURHAM, N.C., June 04, 2021 (GLOBE NEWSWIRE) -- Chimerix (NASDAQ:CMRX), a biopharmaceutical company focused on accelerating the development of medicines to treat cancer and other serious diseases, today announced that the U.S. Food and Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 4, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Ryplazim (plasminogen, human-tvmh) for the Treatment of Plasminogen Deficiency Type 1
LAVAL, QC and CAMBRIDGE, England, June 4, 2021 /CNW Telbec/ - Liminal BioSciences Inc. (Nasdaq: LMNL) ( " Liminal BioSciences " or the " Company " ) announced today that the U.S. Food& Drug Administration (FDA) has approved Ryplazim (plasminogen,... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 4, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Wegovy (semaglutide) to Treat Adults with Obesity
PLAINSBORO, N.J., June 4, 2021 /PRNewswire/ -- Novo Nordisk today announced that the US Food and Drug Administration (FDA) has approved the new drug application (NDA) for Wegovy™ (semaglutide) injection 2.4 mg, the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 4, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Brexafemme (ibrexafungerp) as the First and Only Oral Non-Azole Treatment for Vaginal Yeast Infections
JERSEY CITY, N.J., June 02, 2021 (GLOBE NEWSWIRE) -- Scynexis, Inc. (NASDAQ: SCYX), a biotechnology company pioneering innovative medicines to overcome and prevent difficult-to-treat and drug-resistant fungal infections, today announced that the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 2, 2021 Category: Drugs & Pharmacology Source Type: news

Kedrion and Kamada Announce FDA Approval of KedRAB Label Update, Confirming Safety and Effectiveness in Children
FORT LEE, N.J. and REHOVOT, Israel, June 02, 2021 (GLOBE NEWSWIRE) -- Kedrion Biopharma and Kamada Ltd. (NASDAQ& TASE: KMDA), two leading biopharmaceutical companies specialized in plasma-derived protein therapeutics, announced today the U.S.... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 2, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Lybalvi (olanzapine and samidorphan) for the Treatment of Schizophrenia and Bipolar I Disorder
DUBLIN, June 1, 2021 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced that the U.S. Food and Drug Administration (FDA) has approved Lybalvi (olanzapine and samidorphan) for the treatment of adults with schizophrenia and for the treatment... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 1, 2021 Category: Drugs & Pharmacology Source Type: news

Novartis Cosentyx Receives FDA Approval for Treatment of Children and Adolescents with Moderate to Severe Plaque Psoriasis
EAST HANOVER, N.J., June 1, 2021 /PRNewswire/ -- Novartis, a leader in immuno-dermatology and rheumatology, today announced the U.S. Food and Drug Administration (FDA) has approved Cosentyx (secukinumab) for the treatment of moderate to severe... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 1, 2021 Category: Drugs & Pharmacology Source Type: news

Paratek Pharmaceuticals Announces FDA Approval of Nuzyra (omadacycline) Oral Only Dosing Regimen for the Treatment of Community-Acquired Bacterial Pneumonia (CABP)
BOSTON, June 01, 2021 (GLOBE NEWSWIRE) -- Paratek Pharmaceuticals, Inc. (Nasdaq: PRTK), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel life-saving therapies for life-threatening diseases and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - June 1, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Lumakras (sotorasib) for KRAS G12C-Mutated Locally Advanced Or Metastatic Non-Small Cell Lung Cancer
THOUSAND OAKS, Calif., May 28, 2021 /PRNewswire/ -- Amgen (NASDAQ: AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved Lumakras (sotorasib) for the treatment of adult patients with KRAS G12C-mutated locally advanced... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 28, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Truseltiq (infigratinib) for the Treatment of Cholangiocarcinoma
PALO ALTO, Calif. and LUGANO, Switzerland, May 28, 2021 (GLOBE NEWSWIRE) -- BridgeBio Pharma, Inc. (Nasdaq: BBIO), through its affiliate QED Therapeutics, Inc., and Helsinn Group today announced that the US Food and Drug Administration (FDA) has... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 28, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Pylarify  (piflufolastat F 18) PSMA-Targeted PET Imaging Drug for Men with Prostate Cancer
May 27, 2021 -- FDA has approved Pylarify (piflufolastat F 18)– a drug for positron emission tomography (PET) imaging of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer. With the approval of Pylarify,... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 27, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Biohaven's Nurtec ODT (rimegepant) for Preventative Treatment of Migraine
Nurtec ODT 75 mg is the first oral CGRP antagonist approved to prevent migraine Nurtec ODT 75 mg is now the only migraine medication approved to both treat acute migraine attacks and help prevent future migraine attacks In a pivotal Phase 3... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 27, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Bristol Myers Squibb ’s Zeposia (ozanimod), an Oral Treatment for Adults with Moderately to Severely Active Ulcerative Colitis
PRINCETON, N.J.--(BUSINESS WIRE) May 27, 2021 -- Bristol Myers Squibb (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Zeposia (ozanimod) 0.92 mg for the treatment of adults with moderately to severely active... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 27, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Myfembree as the First Once-Daily Treatment for Heavy Menstrual Bleeding Associated With Uterine Fibroids
BASEL, Switzerland and NEW YORK, May 26, 2021 (GLOBE NEWSWIRE) -- Myovant Sciences (NYSE: MYOV) and Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved Myfembree (relugolix 40 mg, estradiol 1 mg, and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 26, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Camcevi (leuprolide mesylate) for the Treatment of Advanced Prostate Cancer
TAIPEI, May 26, 2021 /PRNewswire/ -- Foresee Pharmaceuticals (6576.TWO), ( " Foresee " ) announced today that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Camcevi 42 mg, a ready-to-use 6-month subcutaneous... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 26, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Rybrevant (amivantamab-vmjw) as the First Targeted Treatment for Patients with Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations
May 21, 2021 (HORSHAM, P.A.)– The Janssen Pharmaceutical Companies of Johnson& Johnson announced today the U.S. Food and Drug Administration (FDA) has granted the accelerated approval of Rybrevant (amivantamab-vmjw) for the treatment of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 21, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Opdivo (nivolumab) as Adjuvant Treatment of Completely Resected Esophageal or Gastroesophageal Junction Cancer in Patients who have Received Neoadjuvant Chemoradiotherapy
PRINCETON, N.J.--(BUSINESS WIRE) May 20, 2021 -- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Opdivo® (nivolumab, injection for intravenous use) for the adjuvant treatment of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 20, 2021 Category: Drugs & Pharmacology Source Type: news

U.S. FDA Approves Opdivo (nivolumab) as Adjuvant Treatment of Completely Resected Esophageal or Gastroesophageal Junction Cancer in Patients who have Received Neoadjuvant Chemoradiotherapy
PRINCETON, N.J.--(BUSINESS WIRE) May 20, 2021 -- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has approved Opdivo® (nivolumab, injection for intravenous use) for the adjuvant treatment of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 20, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Empaveli (pegcetacoplan) for Adults with Paroxysmal Nocturnal Hemoglobinuria (PNH)
WALTHAM, Mass., May 14, 2021 (GLOBE NEWSWIRE) -- Apellis Pharmaceuticals, Inc. (Nasdaq: APLS), a global biopharmaceutical company and leader in targeted C3 therapies, today announced that the U.S. Food and Drug Administration (FDA) has approved... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 14, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Zynrelef (bupivacaine and meloxicam) for the Management of Postoperative Pain
SAN DIEGO, May 13, 2021 /PRNewswire/ -- Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 13, 2021 Category: Drugs & Pharmacology Source Type: news

Injectafer (ferric carboxymaltose injection) Receives FDA Approval for Single Dose Option for the Treatment of Adult Patients with Iron Deficiency Anemia
BASKING RIDGE, N.J. and SHIRLEY, N.Y., May 6, 2021 /PRNewswire/ -- Daiichi Sankyo, Inc. and American Regent, Inc., a Daiichi Sankyo Group company, today announced that the U.S. Food and Drug Administration (FDA) has approved a... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 6, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Merck ’s Keytruda (pembrolizumab) Combined With Trastuzumab and Chemotherapy as First-line Treatment in Locally Advanced Unresectable or Metastatic HER2-Positive Gastric or Gastroesophageal Junction Adenocarcinoma
KENILWORTH, N.J.--(BUSINESS WIRE) May 5, 2021-- Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved Keytruda, Merck’s anti-PD-1 therapy, in... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 5, 2021 Category: Drugs & Pharmacology Source Type: news

Chiesi Global Rare Diseases Announces FDA Approval of Ferriprox (deferiprone) for Treatment of Transfusional Iron Overload due to Sickle Cell Disease
May 1, 2021 Approval is based on demonstrated reduction in liver iron concentration Expanded indications for patients with sickle cell disease or other anemias, as well as thalassemia - BOSTON, May 1, 2021 /PRNewswire/ -- Chiesi Global Rare... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - May 1, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Kloxxado (naloxone hydrochloride) Nasal Spray for Emergency Treatment of Opioid Overdose
LONDON, April 30, 2021 /PRNewswire/ -- Hikma Pharmaceuticals PLC (Hikma), the multinational pharmaceutical company, announces the approval of Kloxxado (naloxone hydrochloride) nasal spray 8mg, by the US Food and Drug Administration (FDA) for the... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 30, 2021 Category: Drugs & Pharmacology Source Type: news

Farxiga Approved in the US for the Treatment of Chronic Kidney Disease in Patients at Risk of Progression With and Without Type-2 Diabetes
30 April 2021 Approval is the most significant advancement in the treatment of chronic kidney disease in more than 20 years In DAPA-CKD Phase III trial, Farxiga demonstrated unprecedented reduction in the risk of the composite of worsening of... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 30, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Zynlonta (loncastuximab tesirine-lpyl) for Relapsed or Refractory Diffuse Large B-Cell Lymphoma
LAUSANNE, Switzerland--(BUSINESS WIRE) APRIL 23, 2021 -- ADC Therapeutics SA (NYSE: ADCT) today announced that the U.S. Food and Drug Administration (FDA) has approved Zynlonta (loncastuximab tesirine-lpyl) for the treatment of adult patients with... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 23, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Jemperli (dostarlimab-gxly) for Women with Recurrent or Advanced dMMR Endometrial Cancer
London UK 22 April 2021 -- GlaxoSmithKline today announced that the US Food and Drug Administration (FDA) has approved Jemperli (dostarlimab-gxly), a programmed death receptor-1 (PD-1) blocking antibody, based on the company’s Biologics... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 22, 2021 Category: Drugs & Pharmacology Source Type: news

U.S. FDA Approves ALK's Ragwitek (Short Ragweed Pollen Allergen Extract) Tablet for Sublingual Use as Immunotherapy for Children and Adolescents With Short Ragweed Pollen-Induced Allergic Rhinitis With or Without Conjunctivitis
ROUND ROCK, Texas, April 19, 2021 /PRNewswire/ -- ALK (ALKB: DC / OMX: ALK B / AKABY / AKBLF), a global, research-driven pharmaceutical company that focuses on the diagnosis and treatment of allergies, announced that the U.S. Food and Drug... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 19, 2021 Category: Drugs & Pharmacology Source Type: news

FDA Approves Opdivo (nivolumab) in Combination with Chemotherapy for Patients with Advanced or Metastatic Gastric Cancer, Gastroesophageal Junction Cancer, and Esophageal Adenocarcinoma Regardless of PD-L1 Expression Status
PRINCETON, N.J.--(BUSINESS WIRE)-- April 16, 2021 Opdivo is the first and only immunotherapy in combination with chemotherapy to deliver superior overall survival versus chemotherapy alone in a trial of this patient population1 U.S. Food and... (Source: Drugs.com - New Drug Approvals)
Source: Drugs.com - New Drug Approvals - April 16, 2021 Category: Drugs & Pharmacology Source Type: news